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FDA Approves First Blood Test For Concussions

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The US Food and Drug Administration has approved the first blood test made to help doctors assess whether or not a brain injury is a concussion.

Traditional evaluations for concussions include a CT scan to determine if a patient has incurred any brain tissue damage, UPI reports. But many people who undergo these scans don’t present any brain lesions that are discernible on screen, according to an FDA news release.

This new test, called the Brain Trauma Indicator, was developed to help tell if there is a need for such scans after a person has suffered a head injury, reducing the need for unnecessary CT tests and cutting down on radiation exposure. It is manufactured by Banyan Biomarkers Inc., in Alachua, Florida.

Scott Gottlieb, FDA Commissioner, said,

Today’s action supports the FDA’s Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging — an effort to ensure that each patient is getting the right imaging exam, at the right time, with the right radiation dose.

In 2013, there were around 2.8 million visits to the emergency room for evaluations of possible concussions, according to statistics from the US Centers for Disease Control and Prevention. Most people who present with concussion symptoms, like impaired memory, problems with movements or sensations, or compromised emotional function, turn out to have negative CT scans, the FDA said.

The Brain Trauma Indicator measures levels of specific proteins that are released from the brain into the bloodstream within 12 hours of a head injury. When the test results come out in four hours, they can then help doctors decide if a CT scan is needed.

The test was assessed in a multi-center study involving 2,000 blood sampled from adults who had suspected concussions. The test accurately predicted the presence of brain lesions 97.5% of the time, proving its mettle as a new tool in brain injuries.

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